冻结乾燥、喷雾乾燥及最新的乾燥技术

有效处方、循环开发与最适化、遵守法规、验证和按比例增加（scale up）的策略

1月12日～13日

此部会网罗与冻结乾燥及新的乾燥技术有关之最新倾向和课题，亦预定举行有关科学已证实的处方、制程最适化、疫苗和生物制剂的冻结/解冻及处方上的课题、从研究开发到按比例提高生产的策略、容器/密闭系统的选定等详细之个案研究及讨论。

处方最适化

Opening Keynote Presentation: Scientific Basis of QbD: Developing a Scientifically Sound Formulation and Optimizing the Lyophilization Process

Michael Pikal, Ph.D., Pfizer Distinguished Endowed Chair in Pharmaceutical Technology & Professor of Pharmaceutics, University of Connecticut

Non-Invasive In-Line Monitoring of Product Temperature during Lyophilization Using Tunable Diode Laser Absorption Spectroscopy (TDLAS)

Puneet Sharma, Ph.D., Postdoctoral Fellow, Pharmaceutical Sciences, University of Connecticut

Innovations for Simplifying Freeze Drying Protocol Development and Optimization

Matthew Ling, Manager, Research and Development, Millrock Technology, Inc.

FTIR Chemical Imaging Guided Lyophilization Formulation and Cycle Development for Recombinant Human Albumin

Heiko Schiffter, Ph.D., Lecturer in Engineering Science (Drug and Vaccine Delivery), Institute of Biomedical Engineering, Department of Engineering Science, University of Oxford

Optical Coherence Tomography (OCT) Based Freeze Drying Microscopy for Collapse Temperature Determination

Kristyn Greco, Ph.D., Postdoctoral Fellow, Pharmaceutics, University of Connecticut

Fast-Dissolving Tablet Vaccines for Enteric and Other Mucosal Pathogens Made by Lyophilization

Dexiang Chen, Ph.D., Senior Technical Officer and Portfolio Leader for Vaccine Formulation, Technology Solutions Global Program, PATH

循环开发

Vial-to-Vial Variation for Freeze-Dried Products during Primary Drying: A New Way to Approach Design Space

Robin Bogner, R.Ph., Ph.D., Associate Professor, Department of Pharmaceutical Sciences, University of Connecticut

Effect of Drying High-Concentration Protein Formulation at, Above and Below Tg乫

Sajal Patel, Ph.D., Scientist, Biopharmaceutical Development, MedImmune

Freeze Drying Above Collapse Temperatures

Gerhard Winter, Ph.D., Professor, Chair of Pharmaceutical Technology and Biopharmaceutics, LMU Munchen

The Importance of Controlling Nucleation Temperature during the Freeze Step

Mark Shon, Vice President, SP Scientific

按比例增加（scale up）

Tech Transfer Considerations during Lyophilization of Highly Concentrated Antibody Formulation: Case Studies Describing Scale-Up from Laboratory to Pilot Scale

Akhilesh Bhambhani, Ph.D., Senior Research Chemist, Vaccine Drug Product Development and New Technology, Merck & Co., Inc.

Incorporating QbD into the Development and Tech Transfer of a Lyophilized Drug Product

Phuong Nguyen, Ph.D., Scientist, Parenteral Formulation Sciences, Millennium: The Takeda Oncology Company

喷雾乾燥和最新的乾燥技术

Biopharmaceutical Powders by Various Drying Technologies for Drug Delivery and Bulk Storage Applications

Mayumi Bowen, Engineer II, Pharmaceutical Processing & Technology Development, Genentech, Inc.

Can We Count on Spray-Drying as a Real Alternative for Freeze-Drying?

Evgenyi Shalaev, Ph.D., Associate Research Fellow, Pharmaceutical Development, Pfizer

New System for the Generation and Delivery of High Concentrations of Respirable Aerosols of Biologics and Large Labile Molecules

Donovan Yeates, Ph.D., CEO, Research and Development, KAER Biotherapeutics